Clinical Impact and Health Economic Studies
A prospective multicenter clinical utility study evaluating the impact of the Breast DCIS Score result upon treatment recommendations for radiation (XRT) therapy has been reported.1 Eligibility criteria included women with newly diagnosed histologically documented DCIS that were eligible for breast conserving therapy. Physicians completed standardized questionnaires that captured their risk of local recurrence and treatment recommendation for XRT, prior to and after receiving the Breast DCIS Score results. A total of 115 evaluable patients from 10 US centers were included in final analyses. Baseline characteristics included median age of 61 years; 74.8% were postmenopausal; median DCIS size 8 mm; 33.9% of tumors were nuclear grade 3, and comedo necrosis was reported as present in 64.4% of cases. Study results found a significant change in the proportion of patients receiving recommendations for XRT pre-vs post-Breast DCIS score result (P=0.008; McNemar’s test). Pre-assay, 73% of patients were recommended to receive XRT which was reduced to 59.1% post-assay. Overall integration of the Breast DCIS Score result into clinical management decisions resulted in a 31.3% change in XRT recommendations. Changes in treatment were bidirectional, indicating that the information was useful both for identifying patients at lower risk or recurrence for whom XRT may be omitted as well as those at higher risk who may be appropriate candidates for more intensive modalities.
Young et al. reported a retrospective health economic study from a single center involving 38 patients for whom the Breast DCIS Score had been ordered.2 In this cohort, 26 patients (68%) had Breast DCIS Score results and local recurrence risk considered low enough to omit radiation from their course of therapy. The authors concluded that the assay has the potential to be cost saving to the healthcare system and spare many patients from the adverse effects associated with radiation therapy.
A cost-effectiveness modeling study comparing the Oncotype DX Breast DCIS Score assay to standard clinical assessment to determine treatment recommendation for radiation therapy has been reported by Alvarado et al.3 The study found that on average, the assay was more cost-effective than the clinical assessment strategy by approximately $1000/patient, with similar life expectancies (17.15 vs 17.11, respectively) and quality-adjusted life-years (QALYs) (16.777 vs 16.789).
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